FDA.reportPublic FDA data

Pain Relief

Manufacturer
Topco | Product Quest Mfg.
Effective date
2018-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:25

Label at a glance#

ProductPain Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure6 sections

Indications and uses

Uses For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritation

Dosage and administration

​Adults and children 2 years of age and older: ​ Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active ingredient                                               Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%                                              Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Uses For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritation

Warnings

WARNINGS SECTION

​For external use only

When using this product • avoid contact with eyes • do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of the children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

​Adults and children 2 years of age and older:​ Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone,  Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, SD Alcohol 40, Steareth-21, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-740-032020-01-31C16284748780-19d75b9d0-3610-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-740-03Pain Relief77 g in 1 CONTAINERCREAM771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-740PAIN RELIEF (LIDOCAINE HCL) CREAM [TOPCO]1Legacy NDC, 1 package rows20180725_58cb1b71-2343-4283-bd5f-4ece0cc92ae2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-74036800-740-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Ceteth-20 Phosphate921FTA1500IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
Dimethicone92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
Ethylhexylglycerin147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MethylparabenA2I8C7HI9TIACT
ALCOHOL3K9958V90MIACT
Steareth-2153J3F32P58IACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
38ede9ed-60d3-4baf-9d81-7eb5266084cb58cb1b71-2343-4283-bd5f-4ece0cc92ae22018-07-25WarningsExact identifier
spl id: 38ede9ed-60d3-4baf-9d81-7eb5266084cb
spl set id: 58cb1b71-2343-4283-bd5f-4ece0cc92ae2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.